REDWOOD CITY, Calif.,
June 27, 2016 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
acute pain, today announced that the company has joined the
broad-market Russell 3000 and Russell 2000 Indexes according to the
final membership lists posted June 24th,
2016.
The Russell 2000® Index measures the performance of the
small-cap segment of the U.S. equity market and is a subset of the
Russell 3000®, representing approximately 10% of the total market
capitalization of that index. Membership in the Russell 3000® Index
includes automatic inclusion in the appropriate growth and style
indexes. FTSE Russell determines membership for its Russell indexes
by objective, market-capitalization rankings and style
attributes.
Indexes provided by FTSE Russell, a leading global index
provider, are widely used by investment managers and institutional
investors for index funds and as benchmarks for active investment
strategies. Approximately $6 trillion
in assets are benchmarked against the Russell US indexes.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for the treatment of acute pain. The company's
late-stage pipeline includes ARX-04 (sufentanil sublingual tablet,
30 mcg) designed for the treatment of moderate-to-severe acute pain
in a medically supervised setting; and Zalviso® (sufentanil
sublingual tablet system) designed for the management of
moderate-to-severe acute pain in adult patients in the hospital
setting.
ARX-04 delivers 30 mcg sufentanil, a high therapeutic index
opioid, sublingually through a disposable, pre-filled, single-dose
applicator. AcelRx has reported positive results from the pivotal
Phase 3 SAP301 ambulatory surgery study, and has advanced ARX-04
into a study (SAP-302) in emergency room patients. In addition,
AcelRx intends to initiate SAP303 in the first quarter of 2016,
with a focus on enrolling patients greater than 40 years of age,
allowing for administration of ARX-04 for up to 12 hours. Zalviso
delivers 15 mcg sufentanil sublingually through a non-invasive
delivery route via a pre-programmed, patient-controlled analgesia
device. In response to the New Drug Application (NDA) AcelRx
submitted to the U.S. Food and Drug Administration (FDA) seeking
approval for Zalviso, AcelRx received a Complete Response Letter
(CRL) on July 25, 2014. The FDA has
requested an additional clinical study (IAP312), which AcelRx is
planning to initiate in the first quarter of 2016, to support
resubmission of the NDA.
For additional information about AcelRx's clinical programs,
please visit www.acelrx.com.
Forward Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to the process
and timing of anticipated future development of AcelRx's product
candidates, ARX-04 (sufentanil sublingual tablet, 30 mcg) and
Zalviso® (sufentanil sublingual tablet system), including the
planned initiation of the IAP312 clinical trial for Zalviso;
anticipated resubmission of the Zalviso NDA to the U.S. Food and
Drug Administration, or FDA; the timing of completion of ARX -04
clinical program and submission of ARX-04 NDA to the FDA; and
the therapeutic and commercial potential of AcelRx's product
candidates, including ARX-04 and Zalviso. These forward-looking
statements are based on AcelRx Pharmaceuticals' current
expectations and inherently involve significant risks and
uncertainties. AcelRx Pharmaceuticals' actual results and timing of
events could differ materially from those anticipated in such
forward-looking statements, and as a result of these risks and
uncertainties, which include, without limitation, risks related to
AcelRx Pharmaceuticals' ability to complete Phase 3 clinical
development of ARX-04 and support ARX-04 development under the
contract with the Department of Defense; AcelRx's ability to
successfully execute the pathway towards a resubmission of the
Zalviso NDA to the FDA, including the initiation and completion of
the IAP312 clinical study for Zalviso; any delays or inability to
obtain and maintain regulatory approval of its product candidates,
including ARX-04 in the United
States and Europe, and
Zalviso in the United States; the
uncertain clinical development process, including adverse events;
the risk that planned clinical trials may not begin on time, have
an effective clinical design, enroll a sufficient number of
patients, or be initiated or completed on schedule, if at all; the
success, cost and timing of all development activities and clinical
trials, including the Phase 3 ARX-04 SAP302 and SAP303 trials, and
the additional clinical trial for Zalviso, IAP312; the fact that
the FDA may dispute or interpret differently clinical results
obtained to date from the Phase 3 SAP301 study of ARX-04; the
market potential for AcelRx's product candidates; and other risks
detailed in the "Risk Factors" and elsewhere in AcelRx's U.S.
Securities and Exchange Commission filings and reports, including
its Quarterly Report on Form 10-Q filed with the SEC on
May 2, 2016. AcelRx undertakes no
duty or obligation to update any forward-looking statements
contained in this release as a result of new information, future
events or changes in its expectations.
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SOURCE AcelRx Pharmaceuticals, Inc.